Chlorpromazine Recall: Zydus Lifesciences lot Z403011, Z407335
The FDA is recalling Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count Rx bottles manufactured by Zydus Lifesciences Ltd. for Northstar Rx LLC, distributed nationwide in the United States, due to CGMP deviations with N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit. The affected lots are Z403011 (Exp 30-04-2026) and Z407335 (Exp 30-11-2026); NDC is 16714-047-01.
| Brand | Zydus Pharmaceuticals (USA) Inc |
|---|---|
| Product | Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-047-01 |
| Reason | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit |
| Severity | moderate |
| Units affected | 10992 |
| Distribution | Nationwide in the USA |
| Agency | FDA |
WHAT YOU SHOULD DO
- If you have a bottle with Lot Z403011 or Z407335, stop using it immediately.
- Do not consume and contact your pharmacist or Northstar Rx LLC for instructions on disposal or replacement.
- Check with your healthcare provider if you have any health concerns or have used the product.
How to identify the recalled item
| Lot / date codes | Lot#: Z403011, Exp Date 30-04-26; Z407335, Exp Date 30-11-26 |
|---|---|
| Lot / date codes | Lots: a) M411147, Expires: 08/2026; M502100, M502099, Expires: 01/2027. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other chlorpromazine recalls
- Chlorpromazine Recall: Amneal 50 mg Tablets · 2026-06-17
- Chlorpromazine Recall: AvKare 100 mg · 2026-03-04
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.